MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24674
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The 80% stenosed target lesion was located in the non-tortuous popliteal vein.A 10.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.When the balloon was inflated, half of it was inside a wallstent and the other half was in the iliac vein.The balloon ruptured at 8 atmospheres and was replaced with another 10.0 x 60, 135cm mustang balloon catheter.The balloon was inflated in the same position and also at 8 atmospheres but the balloon also ruptured.In an attempt to remove the device, the proximal shaft broke off.The device was completely removed together with the 8f sheath from the popliteal vein.A new sheath was introduced and the procedure was completed with a different device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.The shaft of the device was returned in two sections as a result of a complete break located approximately 5mm distal of the proximal balloon bond.The distal section of detached shaft was noted to be severely stretched and accordioned.This type of damage is consistent with excessive tensile force being applied to the device.A visual and microscopic examination identified that the balloon had been inflated.A complete circumferential tear in the balloon material was identified located approximately 10mm distal of the proximal balloon bond.The distal section of balloon material was also torn longitudinally beginning at the circumferential tear and extending approximately 53mm distally across the balloon material.The rated burst pressure for this device is 14 atmospheres as per mustang specification.A visual and microscopic examination found that only one markerband was returned with the device.A visual and microscopic inspection identified no damage or issues with the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The 80% stenosed target lesion was located in the non-tortuous popliteal vein.A 10.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.When the balloon was inflated, half of it was inside a wallstent and the other half was in the iliac vein.The balloon ruptured at 8 atmospheres and was replaced with another 10.0 x 60, 135cm mustang balloon catheter.The balloon was inflated in the same position and also at 8 atmospheres but the balloon also ruptured.In an attempt to remove the device, the proximal shaft broke off.The device was completely removed together with the 8f sheath from the popliteal vein.A new sheath was introduced and the procedure was completed with a different device.No patient complications were reported and the patient was stable.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9410133
• Report Number: 2134265-2019-14606
• Device Sequence Number: 16876453
• Product Code: FGE
• UDI-Device Identifier: 08714729795230
• UDI-Public: 08714729795230
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024149149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: WALLSTENT; STENT: WALLSTENT
• Patient Age: 59 YR